NCT02603172 · OUTCOME

Part A: Maximum Observed Plasma Concentration (Cmax) of GSK3039294 and GSK2315698

A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis · Source last updated 2019-09-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: ng/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 and 48 hours post-dose

What was measured

Blood samples were collected at specified time points for GSK3039294 and GSK2315698. Cmax was determined using standard non-compartmental methods.

Analysis population: PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). NA indicates that data could not be calculated because only one participant was analyzed.

Groups in this outcome

Part A: GSK3039294 200 mg

Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.

Part A: GSK3039294 600 mg

Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.

Part A: GSK3039294 1200 mg

Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Part A: GSK3039294 200 mg	8
Part A: GSK3039294 600 mg	16
Part A: GSK3039294 1200 mg	8

Reported measurements

GSK3039294: n= 1, 10, 6

Analysis denominator · Participants

Group	Source count
Part A: GSK3039294 200 mg	1
Part A: GSK3039294 600 mg	10
Part A: GSK3039294 1200 mg	6

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	30.60	NA	Not reported	Not reported	NA indicates that data could not be calculated because only one participant was analyzed.
Part A: GSK3039294 600 mg	14.82	18.06	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	23.62	56.24	Not reported	Not reported	Not reported

GSK2315698: n= 8, 16, 8

Analysis denominator · Participants

Group	Source count
Part A: GSK3039294 200 mg	8
Part A: GSK3039294 600 mg	16
Part A: GSK3039294 1200 mg	8

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	3.581	23.84	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	3.058	21.78	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	2.476	9.10	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
NA indicates that data could not be calculated because only one participant was analyzed.
group Id
OG000
spread
NA
value
30.60
group Id
OG001
spread
18.06
value
14.82
group Id
OG002
spread
56.24
value
23.62
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
10
group Id
OG002
value
6
units
Participants
title
GSK3039294: n= 1, 10, 6
categories
measurements
group Id
OG000
spread
23.84
value
3.581
group Id
OG001
spread
21.78
value
3.058
group Id
OG002
spread
9.10
value
2.476
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
16
group Id
OG002
value
8
units
Participants
title
GSK2315698: n= 8, 16, 8

denoms

counts
group Id
OG000
value
8
group Id
OG001
value
16
group Id
OG002
value
8
units
Participants

description

Blood samples were collected at specified time points for GSK3039294 and GSK2315698. Cmax was determined using standard non-compartmental methods.

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.
id
OG000
title
Part A: GSK3039294 200 mg
description
Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.
id
OG001
title
Part A: GSK3039294 600 mg
description
Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.
id
OG002
title
Part A: GSK3039294 1200 mg

param Type

GEOMETRIC_MEAN

population Description

PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). NA indicates that data could not be calculated because only one participant was analyzed.

reporting Status

POSTED

time Frame

Pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 and 48 hours post-dose

title

Part A: Maximum Observed Plasma Concentration (Cmax) of GSK3039294 and GSK2315698

type

SECONDARY

unit Of Measure

ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice